A new indication has been added to the instructions for medical use of the innovative oncohematological drug “Brukinza®” (zanubrutinib) – chronic lymphocytic leukemia (CLL)/small cell lymphocytic lymphoma (small lymphocyte lymphoma).

In 2021, the Russian Ministry of Health approved the use of Brookinza® for the indication “mantle cell lymphoma (MCL) in adult patients who have previously received at least one previous therapy.” In August of this year, the drug was recommended for inclusion in the list of vital and essential drugs (VED). This decision was unanimously adopted by the commission of the Ministry of Health of the Russian Federation on the formation of lists of medicines for medical use and the minimum range of medicines necessary for the provision of medical care.

The debut of Brookinza® in our country was made possible thanks to the Nanolek company, which began supplying the drug to Russia in 2021. As part of a strategic agreement concluded with the international oncology company BeiGene, Nanolek received exclusive rights to distribution, promotion, pharmacovigilance, as well as secondary packaging and release control of the drug “Brukinza®” in the Russian Federation and the countries of the Eurasian Economic Union. The company is exploring the issue of deeper localization of the drug at the Nanolek biomedical complex, located in the Kirov region.

Nanolek plans to produce up to 10 thousand packages of Brookinza® in two years. This will make it possible to fully provide for cancer patients in Russia and the EAEU countries. The antitumor drug Brookinza® is used in more than 60 countries around the world to treat various subtypes of B-cell malignancies. The inclusion of the drug in the list of vital and essential drugs increases its availability for two groups of patients: with relapsed or refractory mantle cell lymphoma and with CLL.

Mantle cell lymphoma is one of the rare but most aggressive forms of non-Hodgkin lymphoma, most often found in older people and is diagnosed, in most cases, in an advanced stage. CLL is the most common B-cell tumor. Considering the data obtained from clinical studies among patients with CLL with an unfavorable prognostic set of molecular markers, the use of Brookinza® may improve their quality of life.